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“Please explain Test and Verification in simple terms” – we get this question quite often. A great part of our work at Technolution revolves around building robust test methods. That are focused on generating knowledge and insights early in the development process of medical devices. The foundation for working with medical device test methods is to achieve an understanding of the systems, we work with, during the development process.

 

We analyze data from every lab test

Which can be measured, can often be adjusted. The best way to lower production costs is being aware of tiny adjustments, that can be made early in the development process. In the development of medical devices, this is also a way upon which risks can be taken out of the project early on. We specialize in the development of test solutions for your product verification, in which we focus on data analysis and statistical analysis. Which ensures that our conclusions are valid. That’s why we encourage our customers to do product verification.

It is, of course, possible to conclude on tendencies – and you might get far doing so. You can quickly get a sense of what will happen if you touch and pull stuff. But if you want to get to the next level, where you’ll want to sensibly optimize or develop in a specific and well-structured direction, then a dedicated focus on the test method verification is essential. Say, you need to produce millions of items per year. You want to be able to adjust tiny variables that may render a great reduction in costs in the end. Usually, the production cost is a factor very early on in the process.

Some of our time is spent translating data into benchmarks, in order to make tests easier to repeat for others. Our focus is on the statistical foundation of what it is we are working on. It is imperative for us to have differentiated data, accuracy and that the data review and analysis we create is based on statistics and not conjecture.

 

Test and verification

Verification testing in our lab

Once we have figured out what we want to investigate, we build a simple test setup as fast as possible. This gives some indications as to where we’re headed and what needs to be done, in order to get results. We focus on rapidly being able to generate a hypothesis, from which we can develop further verification testing. In the context of the development process, it is important that we are able to reach insights and new knowledge fast so that we can progress rapidly. And we always want to move forward. It is important to remember, that the process is about learning and generating data, for a better understanding of what we are dealing with.

Our design verification team aims to fast track our test method development. We embrace the principle about rapidly getting functional models, in order to understand the principles for the test itself. As we get deeper into it, we begin refining the test methods. Our mantra is “Learn Fast”.

 

Our experience in medical device verification

Technolution have vast experience within medical device verification and development of devices ranging from mechanical to medical and electronic. And the department of Test and Verification benefits tremendously from this vast amount of experience. We have a strong collaboration with the design control as well as the QA department.

We integrate with the departments of our clients, whom we collaborate with. But at the same time, we must ensure that our documentation and documentation practice comply with our quality systems. We have a focus on both, as well as a holistic understanding of the project. This ensures, that we are moving forward, developing a robust solution.

 

If you want us to help you with test and verification contact us anytime!

Drop Anders a line  or  Call him at +45 40 26 10 00

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